Methods of treating fragile X associated disorders, ADHD, and autism spectrum disorder
Provided are novel methods comprising administering a therapeutically effective amount of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form, to a patient in need thereof.
1. A method of treating a fragile X-associated disorder in a human in need thereof comprising administering to the human a therapeutically effective amount of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form, wherein the fragile-X associated disorder is associated with an expansion to 50 or more repeats of the cytosine guanine guanine (CGG) trinucleotide within the 5′ untranslated region of the FMR1 gene located on the X chromosome and wherein the fragile X-associated disorder is fragile X syndrome (FXS), fragile X-associated tremor/ataxia syndrome (FXTAS), or fragile X-associated primary ovarian insufficiency (FXPOI).
2. A method of treating attention-deficit/hyperactivity disorder (ADHD) in a human in need thereof comprising administering to the human a therapeutically effective amount of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form, wherein the human has a fragile X-associated disorder associated with an expansion to 50 or more repeats of the cytosine guanine guanine (CGG) trinucleotide within the 5′ untranslated region of the FMR1 gene located on the X chromosome.
3. A method of treating autism spectrum disorder (ASD) in a human in need thereof comprising administering to the human a therapeutically effective amount of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form, wherein the human has a fragile X-associated disorder associated with an expansion to 50 or more repeats of the cytosine guanine guanine (CGG) trinucleotide within the 5′ untranslated region of the FMR1 gene located on the X chromosome.
4. The method of claim 1 , wherein (1R,5S)-1-(naphthalen-2-y1)-3-azabicyclo[3.1.0]hexane is in pharmaceutically acceptable salt form.
5. The method of claim 4 , wherein (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane in pharmaceutically acceptable salt form is an acid addition salt.
6. The method of claim 5 , wherein (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane in pharmaceutically acceptable salt form is (1R,5S)-1-(naphthalen-2-y1)-3-azabicyclo[3.1.0]hexane hydrochloride.
7. The method of claim 1 comprising administering 50 mg to 600 mg of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form.
8. The method of claim 1 , wherein (1R,5S)-1-(naphthalen-2-y1)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form, is administered concurrently or sequentially, in either order, with another drug.
9. The method of claim 1 , wherein (1R,5S)-1-(naphthalen-2-y1)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form, is administered in a sustained release pharmaceutical composition.
10. The method of claim 1 , wherein the fragile X-associated disorder is fragile X syndrome (FXS).
11. The method of claim 1 , wherein the fragile X-associated disorder is fragile X-associated tremor/ataxia syndrome (FXTAS).
12. The method of claim 1 , wherein the fragile X-associated disorder is fragile X-associated primary ovarian insufficiency (FXPOI).
13. The method of claim 1 , wherein the fragile-X associated disorder is associated with an expansion to 54 or more repeats of the cytosine guanine guanine (CGG) trinucleotide within the 5′ untranslated region of the FMR1 gene located on the X chromosome.
14. The method of claim 1 , wherein the fragile-X associated disorder is associated with an expansion to 80 or more repeats of the cytosine guanine guanine (CGG) trinucleotide within the 5′ untranslated region of the FMR1 gene located on the X chromosome.
15. The method of claim 2 comprising administering 50 mg to 600 mg of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form.
16. The method of claim 3 comprising administering 50 mg to 600 mg of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form.
17. The method of claim 2 , wherein the fragile X-associated disorder is fragile X syndrome (FXS).
18. The method of claim 2 , wherein the fragile X-associated disorder is fragile X-associated tremor/ataxia syndrome (FXTAS).
19. The method of claim 3 , wherein the fragile X-associated disorder is fragile X syndrome (FXS).
20. The method of claim 3 , wherein the fragile X-associated disorder is fragile X-associated tremor/ataxia syndrome (FXTAS).